RFA Ticker, 6/13/16

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A note about reading the fine print: news circulated last week that NIH was making grants to early-stage investigators of ME/CFS. If you only read the headlines or Twitter, you might think these grants are for research. But they aren’t; the grant even isn’t going directly from NIH to these early-stage investigators. NIH made a grant to the IACFS/ME to support conference registration, travel and hotel expenses for up to 10 early stage investigators. The meeting planning committee, not NIH, will select the investigators for this funding.

I think it’s great that IACFS/ME was successful in getting NIH support for the meeting. I also think it’s important to fund junior investigators to attend conferences because they usually don’t have enough grant money to cover travel expenses. But that’s not the same as supporting research by junior investigators.

In other news, NIH issued an update to an RFA included in the tally for the week of May 23rd. An additional $5 million has been added to the RFA for Diabetes Research Centers. I’ve updated the totals to reflect this.

Otherwise it was a pretty modest week for RFAs. Most people would probably not even sneeze at the total of $7.1 million in RFAs issued last week. But ME/CFS patients know that this exceeds all NIH spending on our disease for all of last year. And that’s nothing to sneeze at.

  • Total RFAs Issued by NIH: 240 (October 2015 to date)
  • Total Dollars Committed to RFAs: $2,093,240,000 (October 2015 to date)
  • Total RFAs for ME/CFS: ZERO (October 2015 to date)
Week Beginning RFAs Issued Total Commitment RFAs for ME/CFS
6/6/16 5 $7,100,000 Zero
5/30/16 4 $6,900,000 Zero
5/23/16 8 $42,400,000 Zero
5/16/16 2 $7,800,000 Zero
5/9/16 11 $32,100,000 Zero
5/2/16 8 $32,485,000 Zero
4/25/16 4 $7,500,000 Zero
4/18/16 10 $42,230,000 Zero
4/18/16 10 $42,230,000 Zero
4/11/16 4 $6,825,000 Zero
4/4/16 8 $27,000,000 Zero
3/28/16 13 $161,000,000 Zero
3/21/16 1 $2,700,000 Zero
3/14/16 5 $23,650,000 Zero
3/7/16 9 $82,710,000 Zero
2/29/16 1 $1,890,000 Zero
2/22/16 9 $30,100,000 Zero
2/15/16 4 $26,500,000 Zero
2/8/16 5 $9,500,000 Zero
2/1/16 8 $26,000,000 Zero
1/25/16 4 $9,300,000 Zero
1/18/16 2 $4,500,000 Zero
1/11/16 10 $71,200,000 Zero
1/4/16 0 $0 Zero
12/28/15 0 $0 Zero
12/21/15 3 $10,260,000 Zero
12/18/15 5 $20,260,000 Zero
12/11/15 27 $765,090,000 Zero
12/4/15 6 $26,600,000 Zero
11/27/15 4 $21,000,000 Zero
11/20/15 15 $134,400,000 Zero
11/13/15 2 $16,100,000 Zero
11/6/15 10 $22,850,000 Zero
10/30/15 7 $49,800,000 Zero
10/23/15 10 $33,200,000 Zero
10/16/15 0 $0 Zero
10/9/15 13 $332,450,000 Zero

If you want more background on the RFA Ticker, read the inaugural post.

Posted in Advocacy, Research | Tagged , , , , , , , , , , , | 5 Comments

RFA Ticker, 6/6/16

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There is an interesting case study among last week’s RFAs. The National Institute of Alcohol Abuse and Alcoholism, along with two other Institutes, issued three RFAs with funding to continue the National Consortium on Alcohol and Neurodevelopment in Adolescence. This caught my eye, given the concept clearance for an ME/CFS consortium.

The National Consortium on Alcohol and Neurodevelopment in Adolescence (NCANDA) has five academic sites and a central data analysis resource. Each site recruits adolescents and collects a standard battery of imaging, cognitive testing, etc. These data are deposited in the central data resource. Each site also collects longitudinal data on the subjects, and runs a research project of its own.

This sounds a lot like the research side of the Centers of Excellence recently recommended by the CFS Advisory Committee. It also sounds a lot like the concept presented by Dr. Vicky Whittemore to the Council of the National Institute of Neurological Diseases and Stroke on May 26th. Dr. Whittemore described “a consortium with multiple sites utilizing common protocols across the clinical projects who can also then develop studies across the sites that would address etiology, potentially imaging, potentially biomarkers studies, genetics, that would all work together.”

Here’s the thing: the three RFAs issued by NIH for NCANDA total $5 million for 2017. That’s it. Five million dollars, and that does not provide funding for actual research projects beyond the characterization of the cohort.

On the one hand, if our RFA following the concept clearance is for $5 million in one year, that’s still $5 million more than we had before. And establishing a consortium for ME/CFS research is an essential step. But on the other hand, NCANDA has a total cohort of only 850 patients. Five million dollars actually does not buy a whole lot, either in the cohort size or support of research.

Don’t get me wrong. I am enthusiastic about the possibility of funding for an ME/CFS consortium. But it’s important to look at other examples in order to gauge our own prospects. Five million dollars to establish an ME/CFS consortium at multiple academic sites plus a central data core would be good news. But it is not sufficient. Not even close.

  • Total RFAs Issued by NIH: 235 (October 2015 to date)
  • Total Dollars Committed to RFAs: $2,081,140,000 (October 2015 to date)
  • Total RFAs for ME/CFS: ZERO (October 2015 to date)
Week Beginning RFAs Issued Total Commitment RFAs for ME/CFS
5/30/16 4 $6,900,000 Zero
5/23/16 8 $37,400,000 Zero
5/16/16 2 $7,800,000 Zero
5/9/16 11 $32,100,000 Zero
5/2/16 8 $32,485,000 Zero
4/25/16 4 $7,500,000 Zero
4/18/16 10 $42,230,000 Zero
4/18/16 10 $42,230,000 Zero
4/11/16 4 $6,825,000 Zero
4/4/16 8 $27,000,000 Zero
3/28/16 13 $161,000,000 Zero
3/21/16 1 $2,700,000 Zero
3/14/16 5 $23,650,000 Zero
3/7/16 9 $82,710,000 Zero
2/29/16 1 $1,890,000 Zero
2/22/16 9 $30,100,000 Zero
2/15/16 4 $26,500,000 Zero
2/8/16 5 $9,500,000 Zero
2/1/16 8 $26,000,000 Zero
1/25/16 4 $9,300,000 Zero
1/18/16 2 $4,500,000 Zero
1/11/16 10 $71,200,000 Zero
1/4/16 0 $0 Zero
12/28/15 0 $0 Zero
12/21/15 3 $10,260,000 Zero
12/18/15 5 $20,260,000 Zero
12/11/15 27 $765,090,000 Zero
12/4/15 6 $26,600,000 Zero
11/27/15 4 $21,000,000 Zero
11/20/15 15 $134,400,000 Zero
11/13/15 2 $16,100,000 Zero
11/6/15 10 $22,850,000 Zero
10/30/15 7 $49,800,000 Zero
10/23/15 10 $33,200,000 Zero
10/16/15 0 $0 Zero
10/9/15 13 $332,450,000 Zero

If you want more background on the RFA Ticker, read the inaugural post.

Posted in Advocacy, Research | Tagged , , , , , , , , , , , | 3 Comments

RFA Ticker, 5/30/16

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NIH took two steps down the road that leads to more ME/CFS research funding last week, but it’s important to understand what those steps actually mean at this point in time.

First, NIH issued a Request for Information: Soliciting Input for New Research Strategies for ME/CFS. A Request for Information (or RFI) is used by federal agencies to gather public comment on a particular topic. A few things stand out about this RFI:

  • The RFI was issued by the Trans-NIH ME/CFS Working Group and sixteen Institutes.
  • The Working Group wants input on: emerging needs and opportunities; challenges or barriers to progress; and gaps and opportunities across the continuum from basic to clinical studies.
  • “[T]he Trans-NIH ME/CFS Working Group will review and consider the comments received under this RFI with regard to current and future needs and direction for ME/CFS research and research training.”
  • The deadline for response is June 24, 2016.

I can’t emphasize enough how important it is for us to respond to this RFI. To my knowledge, it is the first time our opinions have been solicited as part of a planning process. There is no reason that I can see for us not to offer our best input in response to the request.

Second, Dr. Vicky Whittemore presented a “funding concept” for an ME/CFS RFA to the Council of the National Institute for Neurological Diseases and Stroke on May 26th. But what does that actually mean?

A funding concept “describes the basic purpose, scope, and objectives of a potential solicitation of grants or contracts.” “According to law, experts in the field, usually Council members, must approve a concept before we can announce an initiative.” Approval of a concept by Council does not guarantee that it will become an RFA. In other words, Council approval of a funding concept is a bureaucratic hurdle that must be cleared before detailed work on the potential RFA can proceed.

So what did Dr. Whittemore present to the NINDS Council? Fundamentally, “our concept is that we would put in place a consortium with multiple sites utilizing common protocols across the clinical projects who can also then develop studies across the sites that would address etiology, potentially imaging, potentially biomarkers studies, genetics, that would all work together.” These sites will be at academic centers, and will also include a data-management coordinating center. Another goal of the consortia is to gather a large subject cohort who could eventually participate in clinical trials. Participating NIH Institutes will jointly fund the consortia and data center. After only two questions, the concept was approved by the NINDS Council with no objections or abstentions.

There are several critical things to understand about where we are in the process, now that Council has approved the concept:

  • Dr. Whittemore is now able to proceed with drafting the RFA itself. However, there is no guarantee that an RFA will actually be approved and issued.
  • We have no information on how many sites will be funded in this consortia.
  • We have no information on the amount of money that will be allocated to this RFA.
  • We have no information about whether the RFA will fund research directly. It’s possible that it will provide funding for the costs of getting a site up and running, not covering the cost of research projects.
  • We have no information about the timeline. Dr. Whittemore said at CFSAC that she hoped to issue the RFA in June or July and make awards next year. But at least one Institute describes the process as taking six months after concept clearance.
  • We don’t know if these sites will provide clinical care, so we should not assume that these will be Centers of Excellence as CFSAC recently recommended.
  • We don’t know if NIH will wait for the responses to its RFI before issuing this RFA.
  • We don’t know if there will be any other RFAs for research grants.

In other words, there are a lot of blanks that still need to be filled in. This RFA could be spectacular, it could be dreadful, or it could be somewhere in between. We simply do not know. Interestingly, one of the RFAs NIH issued this week was for Diabetes Research Centers. That RFA specifically requires participating Centers to already have at least $3,000,000 in peer-reviewed research underway, and the RFA does not fund research projects; only administrative and core activities are supported. This RFA for Diabetes Research Centers will provide a total of $13,500,000 for up to nine sites in 2018, approximately $1,500,000 per site.

It remains to be seen whether the steps taken by NIH last week will ultimately get ME/CFS research where we need it to go. In the meantime, the RFAs for other research areas keep rolling upwards.

  • Total RFAs Issued by NIH: 231 (October 2015 to date)
  • Total Dollars Committed to RFAs: $2,074,240,000 (October 2015 to date)
  • Total RFAs for ME/CFS: ZERO (October 2015 to date)
Week Beginning RFAs Issued Total Commitment RFAs for ME/CFS
5/23/16 8 $37,400,000 Zero
5/16/16 2 $7,800,000 Zero
5/9/16 11 $32,100,000 Zero
5/2/16 8 $32,485,000 Zero
4/25/16 4 $7,500,000 Zero
4/18/16 10 $42,230,000 Zero
4/18/16 10 $42,230,000 Zero
4/11/16 4 $6,825,000 Zero
4/4/16 8 $27,000,000 Zero
3/28/16 13 $161,000,000 Zero
3/21/16 1 $2,700,000 Zero
3/14/16 5 $23,650,000 Zero
3/7/16 9 $82,710,000 Zero
2/29/16 1 $1,890,000 Zero
2/22/16 9 $30,100,000 Zero
2/15/16 4 $26,500,000 Zero
2/8/16 5 $9,500,000 Zero
2/1/16 8 $26,000,000 Zero
1/25/16 4 $9,300,000 Zero
1/18/16 2 $4,500,000 Zero
1/11/16 10 $71,200,000 Zero
1/4/16 0 $0 Zero
12/28/15 0 $0 Zero
12/21/15 3 $10,260,000 Zero
12/18/15 5 $20,260,000 Zero
12/11/15 27 $765,090,000 Zero
12/4/15 6 $26,600,000 Zero
11/27/15 4 $21,000,000 Zero
11/20/15 15 $134,400,000 Zero
11/13/15 2 $16,100,000 Zero
11/6/15 10 $22,850,000 Zero
10/30/15 7 $49,800,000 Zero
10/23/15 10 $33,200,000 Zero
10/16/15 0 $0 Zero
10/9/15 13 $332,450,000 Zero

If you want more background on the RFA Ticker, read the inaugural post.

Posted in Advocacy, Research | Tagged , , , , , , , , , , , | 22 Comments

Brilliant Scientist Among the #MillionsMissing

My friend Barb opened a window into the extraordinary loss she has endured because of ME/CFS. Please read her powerful statement, and count her among the #MillionsMissing.

Thumbnail.-MillionsMissing-US-205x300If you want a tiny peek into what I live with every day, read what I have written here. I rarely post such an in-depth look publicly, because of the stigma around chronic illness and disability. It hurts when people judge me for how sick I am. And many do. It hurts when people leave me because of chronic illness. Which some do. It hurts when people blame me for being sick. Which some do. So I avoid talking “too much” about the specifics of how bad it is. For some people, talking about it at all is “too much.” But today is the day of the ‪#‎MillionsMissing‬ protest against the government’s inaction regarding Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS), and I can’t go to any of the in-person events because I’m housebound disabled by the illness. I can only protest virtually. So this is my virtual protest: an attempt to educate anyone who cares to learn about the effects of this disease that has stolen my life, and the lives of millions of others like me.

Millions of us are missing from the lives we thought we were going to lead.

I am missing from the work force. I WANT to work. I can’t work any job. I can’t meet deadlines. A few weeks ago, someone offered to pay me to help her do some research for a book she’s writing. I have yet to be able to do a single thing to help. I wanted to try, I’m still trying to try, but my cognitive and other physical functioning is fleeting and unpredictable. I have yet to experience a moment of cognitive function sufficient to allow me to read an article and remember anything I read beyond the first few sentences. I constantly have to start reading over, and retain nothing.

I am missing from any definition of financial security or stability. My meager disability income is insufficient to cover even costs of living. I’m missing from the Medicaid and Food Stamp rolls, because my meager disability income is still higher than the draconically low income cap those programs require. Since I don’t qualify for Medicaid, I don’t qualify for in-home help around the house or errand-running assistance. So I’m 44 years old and dependent on my family for food, shelter and errand-running. It’s quite the indignity for all of us. I am a burden on my family. They love me, but that doesn’t mean they are not burdened by sharing my expenses. My parents should be retired, but they’re working partly in order to support me. My brother also works to support me. That weighs very heavily on me.

I am missing from the grocery store. Even if I could fit food costs into my meager disability income budget (I can’t), I don’t have the strength to go shopping

I am missing from my avocation, sea turtle conservation.

I am missing from field research.

I am missing from laboratory research.

I am missing from wildlife rehabilitation.

I am missing from Herpetology.

I am missing from Marine Biology.

I am missing from Ecology.

I am missing from Environmental Science.

I am missing from Science.

I am missing from Academia. I haven’t even been able to publish my doctoral research because my brain doesn’t work well enough anymore. The article is written, and only needs the final step of finding more recent citations on the subject, but I haven’t even been capable of doing that simple thing for the past eight years that I’ve been disabled.

I AM MISSING FROM MY OWN BRAIN. The loss of my cognitive function, my sharp wit, my brilliance is the most tragic loss I have suffered from this illness. People used to call me a genius. Now I’m average or above average. That might not sound like a big deal to someone who has not suffered the loss of their intellect, but it is a big deal to those of us who have. I can’t read books, I can’t read scientific articles, I can rarely even get through an article in Time magazine if it’s more than half a page. That’s highschool-level reading. My brain is slow, full of fog and mud. Thinking, focusing, concentrating, analyzing, assimilating information, remembering…these are all struggles that wear me out after a short time. So much of the education I busted my ass for has faded away. I expect to get my usual Post-Exertional Relapse from writing this.

I am missing from the stage. I can’t sing any more. Every time I try, I get Post-Exertional Relapse. The technical term is Post-Exertional Malaise, but that term doesn’t adequately describe the debilitating exhaustion and pain that any exercise causes. Singing was one of the greatest pleasures I had in life.

I am missing from the creative world. I used to write poetry, paint, draw, make all kinds of jewelry, make lovely things with polymer clay. I used to have a soaring imagination. Now my head is full of fog, and trying to create anything is like pulling teeth. I have been working on the same necklace for 3 (or is it 4?) months now, and I’m not sure I’m even half done. I am missing from most of my former hobbies, including marine aquariculture and most of herpetoculture. I wouldn’t have any pets if I weren’t willing to spend some of my precious, limited energy on my few small reptile pets. Life without pets is unbearable to me. So I compromise. I borrow energy from the future so I can have a little quality of life with animals now.

I am missing from my friend’s lives. I am missing from social interactions. Weddings, baby showers, barbecues, birthdays, funerals…I can’t travel, so I’m missing all of these things. I couldn’t even go to the funeral of a dear friend. I couldn’t support her husband, either, and he’s a dear friend. The isolation this disease causes is profound and devastating.

I am missing from my own support group. I’m a co-leader of a support group for people like me, yet I’ve only been to one or two of the monthly in-person meetings this year, and have rarely been capable of answering the emails and phone calls that are part of my responsibilities. I WANT to do those things. I WANT to be capable of doing them. I find them fulfilling and uplifting. But they require more physical and cognitive function than I’ve had for a while now.

I am missing from restaurants, movie theaters, plays, and all the other fun extracurricular things I used to take for granted that I can’t do anymore without getting Post-Exertional Relapse.

I am missing from the beach. Sometimes I wonder if a person can literally die from pining for the sea. I wish I were joking. Every year, I see my friend’s photos of their beach vacations, and I feel torn up. I feel whole when I’m at the ocean. It’s my happy place. But I can’t travel, nor do I have the strength to walk down the sand to get to the ocean. So I’m a marine conservationist who hasn’t seen the sea for 10 years.

I am missing from walks in the woods.

I am missing from hikes in the mountains.

I am missing from camping in the wilderness.

I am a naturalist and nature-lover missing from Mother Nature.

I am missing from motherhood. It didn’t happen for me. Now that I’m past reproductive age, it will never happen for me.

I am missing from a loving partnership/relationship. No one wants to date someone as chronically ill as I am. I’ve had nibbles of interest, but they always disappear as soon as they learn how disabled I am. This is what the majority of us experience. Most of us fear that no one will ever love us enough to be able to see past our illness.

I’m missing from a tidy home. I moved into my new place in November of last year, and have only been able to unpack about a dozen boxes. Unpacking is such an epic overexertion that I get Post-Exertional Relapse for days afterwards. Cleaning my own home is a pipe dream.

I am missing from a refreshing night’s sleep. I don’t think I’ve had one this century.

I am missing from pain-free days. I’ve only had one since I came down with the Mononucleosis that developed into ME/CFS in 1996. That one pain-free day happened after I received acupuncture, which I can’t afford now.

I am missing from clinical trials. I have been too sick to travel to the very few that have happened, and can’t afford to pay to participate in the long-distance ones.

I am missing from formal medical education for doctors. There are a handful of doctors in the US who are interested in ME/CFS, and they go out of their way to learn all they can about the disease. But there is little for them to learn, because there is little research or research funding.

I am missing from the only treatment that has made any difference in my symptoms, because Medicare (or most insurance) does not cover Traditional Chinese Medicine, and I can’t afford to pay for it myself. In the 9 years I’ve been disabled, conventional medicine has had nothing to offer me, but herbal medicine made a big difference in my functioning and quality of life when my family and I were able to afford it. That time has come to an end, and so has my hope for recovery as long as the government continues to do nothing. Without government funding for research, large research studies aren’t going to happen and western medicine won’t have anything new to offer us.

I am not alone in any of this.

There are millions of us.

Millions just like me. Some are sicker than me and some are more functional, but all of us struggle to survive with this illness.

Millions dismissed and ignored by the government, medical and research systems.

We are not lazy. We are not crazy. We are not lacking moral fortitude or motivation. We are suffering terribly from an as-yet poorly understood neuroimmune disease. It acts like a neuroimmune disease, anyway. We’d have a better idea of what kind of disease it is if we could get more research going. There was a time when diabetics, people with MS and other invisible diseases that are now legitimized were also dismissed as psychosomatic. What led to legitimacy? Research. What leads to treatments? Research. What leads to research? Government funding.

We need help.

We are sick and tired of surviving, waiting for the government to get its act together and fund research into this disease. We want to LIVE, not just survive. We want to go back to work, or school, or hobbies, or out to eat, or out to a movie, or just have a day in which we don’t have to consider the sickening consequences of every single, tiny thing we do. We would love to have a day in which we could dress ourselves or fix a snack without worrying if we’ll have the energy to eat later. We would love to be able to take having the energy to get out of bed for granted.

Surviving in limbo is hard work.

We just want to LIVE.

Posted in Advocacy, Occupying | Tagged , , , , , , , , , , , , , | 17 Comments

I Am Among the #MillionsMissing

IMG_5469I miss hiking. Getting into the woods, to the enveloping strength of nature, was my favorite thing to do. I wanted to through-hike the Appalachian Trail.

I miss more weddings, graduations, and funerals than I can count.

I miss having children.

I miss being a lawyer. I miss having a career, and working to support myself. I miss the money I could have made, and the lifestyle it would have supported.

I miss my independence. I can’t walk more than a couple minutes and I can’t drive at all. I miss being able to just go to the store when I need something.

I miss having the capacity for normal life.

I miss having multiple projects and priorities, and excelling at all of them.

I miss feeling like I am in command of my body.Thumbnail.-MillionsMissing-US-205x300

I miss believing that every doctor will understand my disease and try to help me.

I miss waking up in the morning feeling rested and ready to start the day.

I miss being spontaneous, instead of meticulously planning every outing for the right timing, right distances, right escape plan.

I miss traveling. I miss believing that it is possible to see what I want to see in the world.

I miss the friends who have fallen away.

I miss throwing dinner parties.

I miss going to concerts.

I miss all the things I am too sick to learn: how to ride a horse, how to shoot a target, how to weave rugs, how to camp backwoods, how to grow food.

Poster-2-300x225I miss having the ability to help others. When my friends and family go through difficult times, I miss being able to bring meals, visit hospitals, clean houses, babysit kids.

I miss having a full, rich, healthy life.

The lack of medical progress, which has sentenced me and millions of others to a life that is less than,  is a direct result of our government’s failure to invest in ME/CFS research. The research dollars must flow. That is our only hope of escape from the life sentence that is this disease.

I am one of the Millions Missing. Don’t let me disappear.

 

 

 

 

Posted in Advocacy, Occupying | Tagged , , , , , , , , , , , , , | 13 Comments

RFA Ticker, 5/23/16

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NIH issued only two RFAs last week, but last week we learned much more about what is coming for ME/CFS.

As I explained in my summary of the CFS Advisory Committee, Dr. Vicky Whittemore reported that she will be presenting a “funding concept” for an RFA to the Council of the National Institute of Neurological Diseases and Stroke on May 26th. If the Council approves her concept, she then will have to seek approval from any other participating Institutes. Once approval from all the funding sources is secured, she (or the Trans-NIH ME/CFS Working Group) will write the RFA. If all goes well, Dr. Whittemore estimated that the RFA would be issued in June or July. Applications would be due in the fall, and funding would begin next year.

In light of NIH policies, Dr. Whittemore could not provide any information about the RFA’s target or budget. We will have to wait for the official announcement. She also seemed to indicate that there could be more than one RFA, although over what time frame is completely unknown. And while Dr. Whittemore seemed confident about the likelihood of the RFA this summer, it should be noted that nothing is guaranteed. The NINDS Council could refuse it, or request modifications. Other participating Institutes (as yet unnamed) may decline as well. And until we can read the RFA, we cannot judge if the concept or amount of funding is sufficient.

I return again to Carol Head’s comments at the CFSAC meeting: “Time is running out to believe in federal changes for funding.” This is the week of the #MillionsMissing protests. I will be missing from my local protest because of this damn disease. I am missing (and have missed) so much of my life. And until there is an actual RFA in my actual hands that actually provides adequate funding for ME/CFS research, I will continue to say there are #MillionsMissing in research dollars.

It’s a very simple equation, really. We are running out of time. And so is NIH.

  • Total RFAs Issued by NIH: 223 (October 2015 to date)
  • Total Dollars Committed to RFAs: $2,036,840,000 (October 2015 to date)
  • Total RFAs for ME/CFS: ZERO (October 2015 to date)
Week Beginning RFAs Issued Total Commitment RFAs for ME/CFS
5/16/16 2 $7,800,000 Zero
5/9/16 11 $32,100,000 Zero
5/2/16 8 $32,485,000 Zero
4/25/16 4 $7,500,000 Zero
4/18/16 10 $42,230,000 Zero
4/18/16 10 $42,230,000 Zero
4/11/16 4 $6,825,000 Zero
4/4/16 8 $27,000,000 Zero
3/28/16 13 $161,000,000 Zero
3/21/16 1 $2,700,000 Zero
3/14/16 5 $23,650,000 Zero
3/7/16 9 $82,710,000 Zero
2/29/16 1 $1,890,000 Zero
2/22/16 9 $30,100,000 Zero
2/15/16 4 $26,500,000 Zero
2/8/16 5 $9,500,000 Zero
2/1/16 8 $26,000,000 Zero
1/25/16 4 $9,300,000 Zero
1/18/16 2 $4,500,000 Zero
1/11/16 10 $71,200,000 Zero
1/4/16 0 $0 Zero
12/28/15 0 $0 Zero
12/21/15 3 $10,260,000 Zero
12/18/15 5 $20,260,000 Zero
12/11/15 27 $765,090,000 Zero
12/4/15 6 $26,600,000 Zero
11/27/15 4 $21,000,000 Zero
11/20/15 15 $134,400,000 Zero
11/13/15 2 $16,100,000 Zero
11/6/15 10 $22,850,000 Zero
10/30/15 7 $49,800,000 Zero
10/23/15 10 $33,200,000 Zero
10/16/15 0 $0 Zero
10/9/15 13 $332,450,000 Zero

If you want more background on the RFA Ticker, read the inaugural post.

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CFS Advisory Committee Meeting Outcomes

productivityThe CFS Advisory Committee is charged with advising the Secretary of Health and Human Services on issues related to ME/CFS. HHS has a very patchy record in its responses to CFSAC recommendations, but the committee’s public meetings remain highly significant. First, the meetings require that the agencies present updates on their ME/CFS-related activities, and we learn a great deal that we otherwise might not know. Second, the committee’s recommendations put the desperate needs of ME/CFS patients on the public record. Third, the meetings provide a venue for the public to speak directly to HHS through public comment.

The CFSAC held its first meeting of 2016 via webinar on May 17th and 18th. Despite being restricted to two half-days, this CFSAC meeting was still quite substantive with important agency updates and committee recommendations.

Agency Updates and Announcements

The Centers for Disease Control provided an update on its ME/CFS activities, including the public Grand Rounds held in February 2016. Dr. Beth Unger described the Technical Development Working Group that CDC has assembled to collect input on its ME/CFS diagnostic material. The Working Group is composed of ME/CFS experts, advocates, patients, as well as representatives from a number of medical associations. However, the charge of the Working Group covers material on diagnosing ME/CFS only. No work will be done on CDC’s educational material on ME/CFS treatments. Dr. Unger also noted that CDC was participating in NIH’s Common Data Elements project, and that no consensus or proposal on changes to the ICD-10 code for ME/CFS has been submitted to the National Center for Health Statistics.

Dr. Suchitra Iyer from the Agency for Healthcare Research and Quality confirmed that some reanalysis of the 2014 systematic evidence review is underway. Specifically, the study authors are reanalyzing treatment studies with those relying on the Oxford definition separated out. They are also reanalyzing results with counseling studies separated from CBT studies. Dr. Iyer stated that an addendum with this reanalysis will be published this summer.

The National Institutes of Health update was provided by Dr. Vicky Whittemore. She stated that the Trans-NIH ME/CFS Working Group has completed a portfolio analysis of NIH-supported research, which will be made available on the website. To promote the interpret-ability of research, NIH will create Common Data Elements to be used in all NIH funded ME/CFS research. A plan for communication with stakeholders is also in preparation. Dr. Whittemore said that NIH will issue a Request for Information on research priorities, which will give the public a chance to weigh in on NIH’s direction. Finally, Dr. Whittemore said she will present a “funding concept” to the Council for the National Institute of Neurological Diseases and Stroke on May 26th. If approved, the concept will then need approval by the participating Institutes. Dr. Whittemore said the Request for Applications would hopefully be issued in June or July, with funding to begin next year.

The Food and Drug Administration held two internal seminars for staff, one delivered by Dr. Lucinda Bateman and the other covering the Patient Focused Drug Development process. Dr. Janet Maynard also reported that the Pharmacy Compounding Advisory Committee recommended that D-Ribose be included on the bulk substances list for use in treating ME/CFS.

Erin Fowler from the Health Resources and Services Administration reported that one HRSA grantee is creating a CFS educational flyer as part of a library of educational materials. Several CFSAC members expressed deep concern that there was no oversight and no clarity as to the involvement of disease experts in creating the flyer. Ms. Fowler agreed to seek more information from the project manager.

Finally, both non-voting liaison members offered updates. Carol Head of the Solve ME/CFS Initiative announced a new patient registry, funded by a grant from the Robert Wood Johnson Foundation, expected to launch in November 2016. Steve Krafchick announced the IACFS/ME conference October 27-30, 2016 in Fort Lauderdale, Florida.

Committee Recommendations

Two CFSAC Working Groups presented recommendations for consideration and vote by the full committee. In both cases, the Working Groups provided extensive background and justification for the proposed recommendations.

First, the Centers of Excellence Working Group led by Dr. Gary Kaplan gave a compelling presentation on the need for Centers of Excellence. The justification for Centers is based on ME/CFS patients being an under-served population with minimal access to expert care. The Working Group found several existing NIH mechanisms for funding Centers, and examples of Centers for other diseases. The Working Group also presented on the concept of “core competencies,” a model to ensure that each Center is able to provide expert clinical care, conduct research and clinical trials, and educate young researchers and healthcare providers. After discussion, CFSAC passed a recommendation that HHS fund twelve Centers of Excellence, attached to academic institutions, for a minimum of five years and total investment of $60 million.

Second, the IOM/P2P Working Group chaired by Donna Pearson revisited and refined their work based on the agency responses to the August 2015 recommendations. First, the Working Group proposed that HHS commit to a review of the IOM diagnostic criteria no later than May 2019. The need for this commitment was underscored by examination of how long the IOM process took, the IOM’s own recommendation that its criteria be reevaluated in no less than five years, and the slow realities of federal processes and meeting planning.

Next, the Working Group recommended that HHS explicitly recognize ME as separate from medically unexplained fatigue or CFS without post-exertional malaise. The recognition of ME as a distinct disease should be marked by new clinical guidelines, new webpages, the new name, and a new ICD code separate from Fukuda CFS. Furthermore, Oxford studies should not be used in ME-related material, as these studies include many patients without ME.

Finally, the Working Group recommended systematic collaboration for disease expert and stakeholder review of all educational materials, and that HHS revisit recommendations 8, 10 and 15 from August 2015. All three of these recommendations were adopted by CFSAC.

Future Directions and Unanswered Questions

Although the working group concept had been met with resistance from some CFSAC members in 2013, this approach to drafting recommendations has resulted in more detailed and better supported recommendations. Working groups are designed to tackle a specific issue, make recommendations to the full committee, and then dissolve. With completion of the Centers of Excellence and IOM/P2P recommendations, discussion turned to future working group topics.

Dr. Faith Newton will lead a working group on pediatrics, specifically to investigate the feasibility of collaboration between HHS and the Department of Education to provide better resources and education to school nurses and parents of school-age ME/CFS patients.

Dr. Dane Cook will lead a working group on how the agencies can incorporate ongoing, robust stakeholder engagement in research. Interestingly, the request for this working group came from the ex officios themselves, especially Dr. Whittemore (NIH).

Finally, Dr. Jose Montoya made a request for a recommendation for a significant increase in research funding. Although this recommendation has been made many, many times before, and as recently as August 2015, Dr. Montoya made a compelling case for why such a recommendation is needed now. He agreed to lead a working group to develop a detailed supporting case.

One topic that received no attention at all during the meeting was the future of CFSAC. The committee’s charter is up for renewal in September 2016. While there was no discussion of the charter renewal, Designated Federal Official Dr. Nancy Lee stated that the committee would meet in October or November, so perhaps we can assume the charter will be renewed.

There was also no discussion of the committee vacancies. Rebecca Collier Patterson did not attend the meeting, presumably because her term expired the day before. Three additional members – Drs. Casillas, Corbin and Fletcher – will see their terms expire on June 13, 2016. Nominations for new members were accepted in April, but there was no word on the timeline for vetting of new members or extensions of the existing terms.

Fourteen members of the public offered comments to the committee on a variety of topics, the most powerful of which were Terri Wilder’s comments about how the history of neglect of the AIDS crisis is repeating itself with ME. But there was one more comment at the end of the meeting that summed up the views of many patients.

timeJust before the close of the meeting, Carol Head of SMCI called for greater urgency from HHS to address the many significant needs of ME/CFS patients. She acknowledged that  NIH has taken some positive steps, and said she is trying to be optimistic. But Head said that it is not clear that the federal government will make the changes demanded by the reports it has commissioned, especially an order of magnitude increase in research funding. Furthermore, in seven months there will be a new administration, and Head asked if we will have to go back to square one with new leaders. Speaking with frankness, Head commented, “Time is running out to believe in federal changes for funding.”

Time is running out in many ways. The time we will be optimistic and “stay the course” with NIH. The time to educate doctors about the new diagnostic criteria. The time to put enough initiatives in place that the change in administration will not slow progress. The time patients have to wait without treatments or competent medical care. Time is running out for us all.

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CFSAC Comments, Terri Wilder

Editor’s note: Terri Wilder made these remarks at the May 18, 2016 meeting of the CFS Advisory Committee. I’m pleased to publish her complete comments, with her permission. For new readers, ME refers to myalgic encephalomyelitis, a neuroimmune disease. 

Good Afternoon. My name is Terri Wilder and I’m a person living with ME.

I should tell you that I was only diagnosed about ten weeks ago so it feels strange for me to introduce myself to you this way as I typically introduce myself this way:

“Good Afternoon, I’m Terri Wilder and I’m an AIDS Activist and a member of ACT UP/NY.”

Yes, that ACT UP–the AIDS Coalition to Unleash Power. The infamous activist organization that shut down the FDA, demanded that the CDC change the definition of AIDS to include women specific illnesses, and stormed the NIH. If you worked in government for any length of time I’m fairly certain you have heard of ACT UP.

While I have only been diagnosed with ME for ten weeks, I can tell you that it didn’t take me very long to figure out that we are repeating history with ME. I have told multiple people that I’m having déjà vu. You see, I have been working in HIV since 1989.

One of the reasons ACT UP was founded was because health officials, government researchers, medical bureaucrats, medical providers and pharmaceutical company executives believed they were the “AIDS experts” when in fact the experts were the people living with AIDS. The persons with AIDS points-of-view were made invisible and their real-world knowledge about the changes that needed to be made to end the crisis, was ignored.

I need to be honest with you and tell you that people told me that nothing would happen today if I gave public comment. Nothing would change and that the government would continue neglecting people like me with ME as they have for the past 30 years by throwing us a few crumbs.

For the past ten weeks I have had two things on my mind—how long am I going to be able to hold on to my job so I don’t lose my health insurance and how could government institutions like the NIH, CDC, HRSA, and FDA repeat history by doing nothing for the millions of people who have this disease?

If I end up really sick in the next few months or years it will not be because the disease or its complications made me sick.

If I’m getting sicker from anything I will be getting sicker from the sexism and pyschogenic views that are so deeply entrenched in this disease, I’ll be getting sicker from the CDC for pushing unexplained fatigue definitions and putting incorrect information on their website about ME, I’ll be getting sicker from the neglect and disdain that has driven away researchers and pharmaceutical companies that could discover a treatment for my disease, and I’ll be getting sicker from government committees that won’t allow people like me (with ME) to sit at that table and help inform policies and programs that might actually save my life. We have a model allowing people like me at the table—people just refuse to use it. I know this because my friends with HIV have a seat at the table.

So how many people are dead either directly or indirectly from this disease who might be alive today if research had been done to develop drugs for ME?

Would they be here today if the government took this disease more seriously and established ME Center’s of Excellence around the country? Would they be here if the government invested funding to the tune of $250 million vs. 5-7 million? Would they be here if the designated federal official for this advisory committee actually had something in her bio on the womenshealth.gov website that actually gave me a clue that she actually had some commitment to ME? The name of the disease can’t be found anywhere in her bio.

So—-how many lives?

Someday, this will be over. Remember that. And when that day comes, there will be people alive on this earth who will hear the story that once there was a terrible disease in this country and that a brave group of people stood up and fought and in some cases gave their lives so that other people might live and be free.

I’m having déjà vu……. and I don’t want history to repeat itself.

If you work for HHS, the CDC, NIH, the FDA or any other government agency—– write down my name.

My name is Terri Wilder and I don’t want my tombstone to say I died of government neglect.

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RFA Ticker, 5/16/16

ticker

NIH cracked the $2 billion mark in RFAs, but there are still #MillionsMissing in essential research dollars for ME/CFS.

  • Total RFAs Issued by NIH: 221 (October 2015 to date)
  • Total Dollars Committed to RFAs: $2,029,040,000 (October 2015 to date)
  • Total RFAs for ME/CFS: ZERO (October 2015 to date)
Week Beginning RFAs Issued Total Commitment RFAs for ME/CFS
5/9/16 11 $32,100,000 Zero
5/2/16 8 $32,485,000 Zero
4/25/16 4 $7,500,000 Zero
4/18/16 10 $42,230,000 Zero
4/18/16 10 $42,230,000 Zero
4/11/16 4 $6,825,000 Zero
4/4/16 8 $27,000,000 Zero
3/28/16 13 $161,000,000 Zero
3/21/16 1 $2,700,000 Zero
3/14/16 5 $23,650,000 Zero
3/7/16 9 $82,710,000 Zero
2/29/16 1 $1,890,000 Zero
2/22/16 9 $30,100,000 Zero
2/15/16 4 $26,500,000 Zero
2/8/16 5 $9,500,000 Zero
2/1/16 8 $26,000,000 Zero
1/25/16 4 $9,300,000 Zero
1/18/16 2 $4,500,000 Zero
1/11/16 10 $71,200,000 Zero
1/4/16 0 $0 Zero
12/28/15 0 $0 Zero
12/21/15 3 $10,260,000 Zero
12/18/15 5 $20,260,000 Zero
12/11/15 27 $765,090,000 Zero
12/4/15 6 $26,600,000 Zero
11/27/15 4 $21,000,000 Zero
11/20/15 15 $134,400,000 Zero
11/13/15 2 $16,100,000 Zero
11/6/15 10 $22,850,000 Zero
10/30/15 7 $49,800,000 Zero
10/23/15 10 $33,200,000 Zero
10/16/15 0 $0 Zero
10/9/15 13 $332,450,000 Zero

If you want more background on the RFA Ticker, read the inaugural post.

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PACE-Gate

opendataIt is International ME/CFS Awareness Day, and what is most on my mind is the status of PACE-Gate: the controversy over the design, conduct and results of the PACE trial. PACE is the largest clinical trial in ME/CFS, and it compared graded exercise therapy, adaptive pacing, supportive medical care, and cognitive behavioral therapy (explicitly targeting patients’ false beliefs about their illness). The first paper on the results was published in The Lancet in 2011, but there are dozens of flaws in the design and conduct of the study. Requests for data and reanalysis of conclusions are in process across many fronts. While PACE is of intense interest to the ME/CFS community because its results have been used as the basis of treatment recommendations, the issues have significant implications beyond ME/CFS for both scientists and the journals involved.

PACE-Gate was launched by academic/journalist David Tuller, DrPH (Lecturer at the School of Public Health and Graduate School of Journalism at University of California, Berkeley) with his 2015 article series, Trial By Error, which dismantled the bad science in PACE. Tuller was assisted by the work of many “citizen scientists,” ME/CFS patients who worked for years to carefully analyze the study and as much data as they could obtain.

For five years, ME/CFS patients have known and insisted that the results of the study  – even if it had been perfectly designed and conducted – are not applicable to us because the subjects were fatigued, and were not all suffering from ME/CFS. But as Dr. Tuller covered in such detail, the study was the opposite of perfectly designed and conducted. Subjects could worsen during the course of the trial and still be counted as recovered at the end because of post hoc changes in study design – and that is just one of dozens of fundamental flaws in the PACE trial. Yet still, the study is hailed as the largest clinical trial in our disease and as proof that we only need to exercise and shed the “belief” that we are sick in order to recover. Reminiscent of launching a thousand ships, Dr. Tuller’s articles kicked the bad science scandal into high gear, and efforts to expose the truth about PACE began to multiply.

Attempts to secure data from the PACE trial – anonymized to protect patients, of course – are of interest to scientists inside and outside the world of ME/CFS. As they have done for years, the PACE authors continue to block these efforts. In November 2015, Dr. James Coyne (Professor of Health Psychology at University Medical Center, Groningen, the Netherlands) filed a request for the data from the PLoS ONE article on the cost-effectiveness of the treatments evaluated in the PACE trial. King’s College London refused the request, claiming it was “vexatious.” This set off a flurry of protests from scientists, including those at Retraction Watch who called the reasons for rejection “absurd.” Dr. Coyne made PLoS aware of his request, since its policies require authors to make data available for papers published in PLoS journals. As of May 9, 2016, Dr. Coyne has still not received the data, and it is unclear if PLoS will actually enforce its data sharing policy. Dr. Coyne told me, “I am leaving things in PLoS’s hands. I am considering a range of responses if the Journal does not produce the data or retract the paper.”

Graphic credit: Radhika Bhatt, U.S. Department of Commerce Data Service

Graphic credit: Radhika Bhatt, U.S. Department of Commerce Data Service

In December 2015, Dr. Tuller was joined by Dr. Vincent Racaniello (Professor of Microbiology and Immunology, Columbia University), Dr. Ron Davis (Professor of Biochemistry & Genetics, Stanford University) and Dr. Bruce Levin (Professor of Biostatistics, Columbia University) in filing a request for “the raw data for all four arms of the trial” on the original primary outcomes and measures of recovery. This request was denied by Queen Mary University of London in January 2016. Dr. Tuller told me that they appealed this decision, but QMUL declined to undertake a review. Tuller and the other scientists filed an appeal with the Information Commissioner’s Office, but they expect it to take many months for the ICO to come to a decision.

Valerie Eliot Smith has been tracking the slow progress in the case of another PACE data request to QMUL. Alem Matthees filed a request for PACE data, QMUL refused, and he appealed to the ICO. The Information Commissioner ruled in his favor, but QMUL appealed that decision to the First-Tier Tribunal (Information Rights). That hearing was held at the end of April and a decision is expected very soon.

In the absence of direct access to the data, multiple requests for independent review of the PACE data have been made. In November 2015, Dr. Vincent Racaniello and five colleagues published an open letter to Dr. Richard Horton, Editor of The Lancet, urging the publication to “seek an independent re-analysis of the individual-level PACE trial data.” After three months without a response from Dr. Horton, Dr. Racaniello published the open letter again, this time joined by an additional thirty-six scientists. Dr. Racaniello told me that Dr. Horton “invited us to submit it as an ‘official’ letter to Lancet, which would be published; and we did that. No response from him or Lancet yet.” Dr. Horton did not respond to my request for comment on when this letter will be published.

wheelchair_protestAt the same time, twelve U.S. ME/CFS organizations asked the Centers for Disease Control and the Agency for Healthcare Research and Quality to examine the issues raised in Dr. Tuller’s investigation. In part, the organizations asked that the CDC remove all recommendations based on the PACE trial from its medical education material, and asked AHRQ to revise its systematic evidence review in light of the concerns regarding the PACE trial and the Oxford case definition. Mary Dimmock informed me that AHRQ agreed to “reanalyze results by case definition and also separate out CBT from general counseling,” but there is no timeline for this revision of the systematic review.

Advocates have not been silent, either. More than 2,200 people joined in the requests of CDC and AHRQ. More than 12,000 people signed an MEAction petition demanding retraction of claims made in PACE papers in The Lancet and Psychological Medicine, and further asking that independent researchers be given full access to the anonymized raw data from the trial.

I asked Dr. Tuller where he thinks the PACE controversy is headed. He said, “I have to believe that the scientific community will gradually demand that it get retracted or the pressure to release the data will be so overwhelming that QMUL will finally decide that its institutional interests diverge from those of the authors. Perhaps the tribunal will make a strong argument in favor of data release–or perhaps the opposite. I don’t know.”

ignoreDr. Racaniello was not as optimistic. He said, “I think they are going to ignore, obfuscate, and give their usual responses until we are all dead. I don’t have hope that the PACE authors, or Lancet, will respond in any meaningful way until there is more of an outcry.”

What can we do? Dr. Racaniello said, “Share David Tuller’s articles on what is wrong with the study. If these are too complex, use his bullet point summaries. The patient community has been active but we need more scientists and physicians to weigh in on the problem.”

I think the opinions of scientists are the key to a solution here. Dr. Racaniello told me, “I think it’s bad science that was poorly reviewed. Why Lancet is not willing to re-investigate is a mystery.” The Lancet  has faced this problem before. PLoS appears to be back pedaling from enforcing its own data sharing policies. The PACE authors and their universities are refusing every data request at every turn. And unlike the previous five years, the Lancet, PLoS, PACE authors, and universities are not doing this to allegedly vexatious patients who are allegedly part of an allegedly vast conspiracy to make their lives difficult. The Lancet, PLoS, PACE authors and universities are doing it to scientists not previously associated with ME/CFS.

My experience as an ME/CFS advocate has taught me that this disease is the perfect case study for many issues in research, policy and medical care. The PACE trial is one such example. All scientists who care about strong peer review, open data, and verification of results should care about PACE, even if they don’t give a hoot about ME/CFS. Anyone who cares about translating good science into policy, medical education and healthcare should care about PACE, even if they are not interested in ME/CFS.

But as I said last year, and I say again this year: We will not see the change that we need and the resource investment that we need until we find a way to leverage the awareness into action. As advocates, we should do everything we can to communicate about the PACE issues to scientists outside the ME/CFS community. They can help boost the signal enough to get the Lancet, PLoS, PACE authors and universities to pay attention and take the necessary actions to bring PACE-Gate to the correct conclusion.

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